Category: fda

In our previous article, we covered FDA new drug approvals for 2018. In the present article, we look at patent filings, litigation, regulatory and clinical data, related to these drug approvals, as a case study of fusing complementary data sources to provide comprehensive pharma competitive intelligence.

FDA’s Center for Devices and Radiological Health (CDRH) approved a record-breaking 106 new medical devices in 2018. Medical devices approved by the FDA include Class I, Class II and Class III devices, categorized based on the potential risks involved in their use. Read all about it in this month's newsletter.

The pharma industry and US FDA will reflect on a record breaking 2018 for drug approvals. The Center for Drug Evaluation and Research (CDER) approved 59 new drugs last year which is a significant increase from previous years (FIG. 1; area plots). In the last 10 years, the FDA has approved 271 novel drugs and 85 biologics (FIG. 1, line plots). The new approvals for 2018 includes 42 new molecular entities and 17 new biologics. Small molecules dominate the list contributing to 64% of the approved drugs, while antibodies represent another 20%. There was a 40% increase in approvals of cancer therapies as compared to 2017. Increased approval trends were observed towards the end of the year with the last quarters accounting for more than 70% of the approved drugs. Oral dosage forms, such as tablets and capsules, accounted for greater than 80% of approved drugs (FIG. 2).

In this issue, we have covered a couple of hot topics that are currently trending in the biotech and cloud-tech industries. We have talked about the FDA's approval of tisagenlecleucel (KYMRIAH, Novartis Pharmaceuticals Corp.), a CD19-directed genetically modified autologous T-cell immunotherapy, to include treatment of patients with relapsed or refractory large B-cell lymphoma. Tisagenlecleucel is the only CAR T-cell therapy to receive FDA approval for two distinct indications. The report includes a chart of major commercial players in the CAR T-cell space and a Year-on-Year trend on the number of patents and patent applications from 2012 to 2018.